510(k) Report

Devices descending from K990131

224 later devices reach Pro Osteon Implant 500R Resorbable Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+6K213757Endocem MTA Premixed RegularMaruchi20230—
+6K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+6K221811Vista BC SealerInter-Med, Inc.20220—
+6K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+6K202015White ENDOSEAL MTAMaruchi20211—
+6K201799CleaniCalMaruchi20212—
+6K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+6K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+6K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+6K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+7K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+7K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+7K243353One-Fil PuttyMediclus Co., Ltd.20251—
+7K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+7K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+7K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+7K211905UltraCal XSUltradent Products, Inc.20210—
+7K212229White Endoseal MTAMaruchi20210—
+7K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+8K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+8K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+8K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—